HypoglycemiaPhase 2NCT01972152
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
A Phase 2 study testing G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg and G-Pen(TM) 0.5 mg in people with Hypoglycemia, run by Xeris Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg and G-Pen(TM) 0.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between the ages of 18 and 60 years of age, inclusive, at Screening.
- Women must be of non-childbearing potential as defined by one of the following:
- Females who are >45 and < 60 years of age at Screening and amenorrheic for at least 2 years
- Females who have had a documented hysterectomy and/or bilateral oophorectomy.
- Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):
- Oral contraceptive
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- Injectable progesterone
- Subdermal implant
- Spermicidal foam/gel/film/cream/suppository
- Diaphragm with spermicide
- Copper or hormonal containing intrauterine device (IUD)
- Sterile male partner vasectomized > 6 month pre-dosing.
- Male subjects are required to use a condom and one of the methods of contraception in 2. or 3. above starting at Randomization and for the duration of the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.
Who cannot join
- Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.
- Mean of triplicate set of seated BP readings at Screening, confirmed by 1 set of triplicate at Screening, if deemed necessary where systolic blood pressure (SBP) <90 or >140 mm Hg, and diastolic blood pressure (DBP) <50 or >90 mm Hg.
- Cardiovascular event within 6 months prior to screening such as unstable angina, acute coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery By-pass Grafting (CABG)), stroke or transient ischemic attack.
- Clinically significant ECG abnormalities.
- Study participants who are pregnant at Screening are not eligible for this study.
- Breast feeding must be discontinued if a subject wishes to participate in this study.
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- Positive test for hepatitis B, hepatitis C, or HIV found at Screening.
- Positive urine drug test for illicit drugs at Screening.
- Allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation.
- Recent (i.e., within three (3) months prior to Screening) administration of glucagon.
- Any prior cerebrovascular accident or major permanent neurological damage such as aphasia, hemiparesis, or dementia.
- Peripheral artery disease with uncontrolled claudication
- Current diagnosis or current clinical evidence of any New York Heart Association classification of heart failure.
- Subjects with any of the following abnormalities in clinical laboratory tests at Screening, confirmed by a single repeat, if necessary:
- Total bilirubin > 1.5x upper limit of normal (ULN)
- aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5x ULN.
- Creatinine > 2.5x ULN.
- History of regular alcohol consumption as defined by alcohol intake in a quantity exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor.
- Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study and during participation in the current study.
- Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Diabetes Institute, University Health System
San Antonio, Texas, 78207
About this study
Official title: A RANDOMIZED, PHASE 2, DOUBLE-BLIND, 3-WAY CROSSOVER STUDY WITH G-PEN™ (GLUCAGON INJECTION) TO EVALUATE SAFETY, TOLERABILITY AND COMPARATIVE PHARMACOKINETICS AND PHARMACODYNAMICS TO LILLY GLUCAGON™ (GLUCAGON FOR INJECTION [rDNA ORIGIN]) IN HEALTHY VOLUNTEERS
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
Read the detailed description
Primary objective: To Evaluate the Safety and Tolerability of G-Pen™ (Glucagon Injection) 1 mg
Secondary objective (1): To Evaluate the pharmacodynamics (Efficacy) of G-Pen™ (Glucagon Injection) 1 mg
Secondary objective (2):To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg [test] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for injection [rDNA origin]) 1 mg (reference)
- Conditions
- Hypoglycemia
- Being tested
- G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg, G-Pen(TM) 0.5 mg
- Keywords
- Hypoglycemia, Glucagon
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-Pen(TM) 1 mgDrug
Lilly Glucagon(TM) 1 mgDrug
G-Pen(TM) 0.5 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| G-Pen(TM) 1 mg | Experimental | G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection Receives: Drug: G-Pen(TM) 1 mg; Drug: Lilly Glucagon(TM) 1 mg; Drug: G-Pen(TM) 0.5 mg |
| G-Pen(TM) 0.5 mg | Experimental | G-Pen(TM) (glucagon injection), single 0.5 mg SC injection Receives: Drug: G-Pen(TM) 1 mg; Drug: Lilly Glucagon(TM) 1 mg; Drug: G-Pen(TM) 0.5 mg |
| Lilly Glucagon(TM) 1 mg | Active comparator | Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection Receives: Drug: G-Pen(TM) 1 mg; Drug: Lilly Glucagon(TM) 1 mg; Drug: G-Pen(TM) 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Number of serious adverse events (SAEs) per treatment group
Measured: From first dose until completion of the post-treatment follow-up visit, up to 6 weeks
Secondary outcomes (9)
Glucose Area Under the Curve (AUC)
Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Cmax
Pharmacodynamic parameter: Maximum concentration of glucose
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Tmax
Pharmacodynamic parameter: Time to Maximum Glucose Concentration
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose AUCex
Pharmacodynamic parameter: Area Under the Glucose Excursion Curve
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose MAE
Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Tex
Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon AUC
Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon Cmax
Pharmacokinetic parameter: Maximum concentration of glucagon
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon Tmax
Pharmacokinetic parameter: Time to maximum concentration of glucagon
Measured: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emissary International LLC
- Responsible party
- Sponsor
- Investigators
- Ralph A DeFronzo, MD, Principal investigator, Texas Diabetes Institute, University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972152
- Sponsor's protocol ID
- XSGP-201
- Other IDs
- 2R44DK085809-02
- Status last verified
- Jan 2016
- First submitted
- 18 Oct 2013
- Last updated
- 3 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, PHASE 2, DOUBLE-BLIND, 3-WAY CROSSOVER STUDY WITH G-PEN™ (GLUCAGON INJECTION) TO EVALUATE SAFETY, TOLERABILITY AND COMPARATIVE PHARMACOKINETICS AND PHARMACODYNAMICS TO LILLY GLUCAGON™ (GLUCAGON FOR INJECTION [rDNA ORIGIN]) IN HEALTHY VOLUNTEERS
- ClinicalTrials.gov ID
- NCT01972152
- Acronym / sponsor ID
- XSGP-201
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, Glucagon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Xeris PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emissary International LLC
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
Detailed description
Primary objective: To Evaluate the Safety and Tolerability of G-Pen™ (Glucagon Injection) 1 mg
Secondary objective (1): To Evaluate the pharmacodynamics (Efficacy) of G-Pen™ (Glucagon Injection) 1 mg
Secondary objective (2):To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg [test] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for injection [rDNA origin]) 1 mg (reference)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G-Pen(TM) 1 mg | Experimental | Drug: G-Pen(TM) 1 mg, Drug: Lilly Glucagon(TM) 1 mg, Drug: G-Pen(TM) 0.5 mgG-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection |
| G-Pen(TM) 0.5 mg | Experimental | Drug: G-Pen(TM) 1 mg, Drug: Lilly Glucagon(TM) 1 mg, Drug: G-Pen(TM) 0.5 mgG-Pen(TM) (glucagon injection), single 0.5 mg SC injection |
| Lilly Glucagon(TM) 1 mg | Active comparator | Drug: G-Pen(TM) 1 mg, Drug: Lilly Glucagon(TM) 1 mg, Drug: G-Pen(TM) 0.5 mgLilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy male or female subjects between the ages of 18 and 60 years of age, inclusive, at Screening.
- Women must be of non-childbearing potential as defined by one of the following:
- Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):
- Male subjects are required to use a condom and one of the methods of contraception in 2. or 3. above starting at Randomization and for the duration of the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (21 listed)
- Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.
- Mean of triplicate set of seated BP readings at Screening, confirmed by 1 set of triplicate at Screening, if deemed necessary where systolic blood pressure (SBP) <90 or >140 mm Hg, and diastolic blood pressure (DBP) <50 or >90 mm Hg.
- Cardiovascular event within 6 months prior to screening such as unstable angina, acute coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery By-pass Grafting (CABG)), stroke or transient ischemic attack.
- Clinically significant ECG abnormalities.
- Study participants who are pregnant at Screening are not eligible for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-Pen(TM) 1 mg | Drug | G-Pen(TM) 0.5 mg, G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg |
| Lilly Glucagon(TM) 1 mg | Drug | G-Pen(TM) 0.5 mg, G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg |
| G-Pen(TM) 0.5 mg | Drug | G-Pen(TM) 0.5 mg, G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg |
Primary outcome
Serious Adverse Events
Time frame: From first dose until completion of the post-treatment follow-up visit, up to 6 weeks
Number of serious adverse events (SAEs) per treatment group
9 secondary outcomes
Glucose Area Under the Curve (AUC)
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Cmax
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Tmax
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose AUCex
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose MAE
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Tex
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon AUC
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon Cmax
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon Tmax
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph A DeFronzo, MD principal investigator
Texas Diabetes Institute, University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg and G-Pen(TM) 0.5 mg in people with Hypoglycemia, run by Xeris Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: From first dose until completion of the post-treatment follow-up visit, up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.